FDA product code HLA: Calibrator, Tonometer
HLA is the FDA product code for calibrator, tonometer. It is a Class II device, regulated under 21 CFR 886.1930 and reviewed by the Ophthalmic panel. Devices under HLA reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Calibrator, Tonometer |
| Device class | Class II |
| Regulation | 21 CFR 886.1930 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for HLA devices
openFDA lists no recalls for product code HLA.
Frequently asked questions
What is FDA product code HLA?
HLA is the FDA product code for calibrator, tonometer. It is a Class II device, regulated under 21 CFR 886.1930 and reviewed by the Ophthalmic panel.
What device class is HLA?
Class II, regulation 21 CFR 886.1930. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code HLA
- Run a recall and safety report across every HLA manufacturer
- Watch product code HLA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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